---
title: Effect of TrueTear Corneal Surface Imaging
nct_id: NCT03637348
overall_status: COMPLETED
phase: NA
sponsor: Price Vision Group
study_type: INTERVENTIONAL
primary_condition: Cataract
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03637348.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03637348"
ct_last_update_post_date: 2020-08-11
last_seen_at: "2026-05-12T06:44:39.484Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of TrueTear Corneal Surface Imaging

**Official Title:** Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality

**NCT ID:** [NCT03637348](https://clinicaltrials.gov/study/NCT03637348)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** Price Vision Group
- **Collaborators:** Allergan
- **Conditions:** Cataract, Myopia
- **Start Date:** 2018-08-13
- **Completion Date:** 2019-07-08
- **CT.gov Last Update:** 2020-08-11

## Brief Summary

This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.

## Detailed Description

Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery

Exclusion Criteria:

* A cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck
* Chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding
* A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the TrueTearTM device
* Pregnancy
* Presence of any ocular disease or condition which in the investigator's opinion would confound the study results
```

## Arms

- **TrueTear** (OTHER) — Use of TrueTear device to stimulate tear production

## Interventions

- **TrueTear** (DEVICE) — Ues of TrueTear neurostimulator

## Primary Outcomes

- **Surface Asymmetry Index (SAI) Assessed With Corneal Topography** _(time frame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.)_ — Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure.

## Secondary Outcomes

- **Surface Regularity Index (SRI) Assessed With Corneal Topography** _(time frame: Change from baseline SRI at 5-10 minutes after using the TrueTear device.)_

## Locations (1)

- Price Vision Group, Indianapolis, Indiana, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.price vision group|indianapolis|indiana|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03637348.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03637348*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*